| CTRI Number |
CTRI/2019/04/018454 [Registered on: 08/04/2019] Trial Registered Prospectively |
| Last Modified On: |
02/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of sleep related breathing disorders in patients with prolonged heart failure. |
|
Scientific Title of Study
|
Study of sleep disordered breathing in chronic heart failure patients |
| Trial Acronym |
SDBCHF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAJIT KISHAN GOLLAPALLI |
| Designation |
REGISTRAR |
| Affiliation |
kasturba medical college, manipal |
| Address |
DEPT. OF CARDIOLOGY,
KMC, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9505666002 |
| Fax |
|
| Email |
sajitkishan1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PADMAKUMAR RAMACHANDRAN |
| Designation |
Professor and head of unit |
| Affiliation |
kasturba medical college, manipal |
| Address |
DEPT. OF CARDIOLOGY,
KMC, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9900921428 |
| Fax |
|
| Email |
padmakumar69@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SAJIT KISHAN GOLLAPALLI |
| Designation |
REGISTRAR |
| Affiliation |
kasturba medical college, manipal |
| Address |
DEPT. OF CARDIOLOGY,
KMC, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9505666002 |
| Fax |
|
| Email |
sajitkishan1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| LIFE PLUS MEDICAL
Office.No.2-4-14B3, 1st Floor, Raaj Towers City Bus stand, Udupi - 576101
|
|
|
Primary Sponsor
|
| Name |
LIFE PLUS MEDICAL |
| Address |
LIFE PLUS MEDICAL
Office.No.2-4-14B3, 1st Floor, Raaj Towers City Bus stand, Udupi - 576101
|
| Type of Sponsor |
Other [MEDICAL EQUIPMENT COMPANY] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SAJIT KISHAN GOLLAPALLI |
KASTURBA HOSPITAL |
DEPARTMENT OF CARDIOLOGY,
KASTURBA HOSPITAL & MEDICAL COLLEGE,
MANIPAL-576104
Udupi
KARNATAKA |
9505666002
sajitkishan1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
OVERNIGHT POLYSOMNOGRAPHY |
IN HOSPITAL SCREENING FOR SLEEP DISORDERED BREATHING WITH OVERNIGHT POLYSOMNOGRAPHY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
CHRONIC HEART FAILURE IN-HOSPITAL PATIENTS WHO HAVE RECOVERED FROM AN ACUTE DECOMPENSATION |
|
| ExclusionCriteria |
| Details |
1.DECOMPENSATED HEART FAILURE PATIENTS REQUIRING OXYGEN SUPPORT.
2.RECENT ACUTE CORONARY SYNDROME (ACS) OR STROKE IN LAST 3 MONTHS.
3.PREGNANT WOMEN.
4.PATIENT WITH PREVIOUSLY DIAGNOSED SDB WHO ARE ON THERAPY
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PREVALENCE OF SDB, PREVALENCE OF CSA AND OSA, IN CHRONIC HEART FAILURE IN-PATIENTS. |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
COMPARISON OF VARIOUS DEMOGRAPHIC PARAMETERS WITH PREVALENCE OF SDB.
|
1 YEAR |
CORRELATION OF LV DYSFUNCTION (LVEF) AND NTPROBNP LEVELS WITH AHI AND RDI.
|
1 YEAR |
CORRELATION OF ESS SCORES, STOP BANG SCORES, BERLIN QUESTIONNAIRE SCORES WITH AHI AND RDI.
|
1 YEAR |
ASSOCIATION OF VARIOUS CO-MORBIDITIES (TYPE 2 DIABETES, HTN, DYSLIPIDEMIA) WITH SDB.
|
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. JavaheriS., et al., Sleep apnea in 81 ambulatory male patients with stable heart failure. Types and their prevalences, consequences, and presentations. Circulation, 1998. 97(21): p. 2154–2159
2. SinDD, FitzgeraldF, ParkerJD, et al: 1999. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med 160:1101–1106 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS RESEARCH PROJECT HAS BEEN STIMULATED BY ACCUMULATING EVIDENCE THAT SDB DISORDERS ARE IMPORTANT MODIFIERS OF DISEASE PROGRESSION AND TREATMENT IN PATIENTS WITH HEART FAILURE. HEART FAILURE PATIENTS HAVE OCCULT SDB, THEREFORE GO UNDETECTED. THE RESULTS OF THIS STUDY WOULD AID IN DETERMINING THE SAME, MODIFYING TREATMENT STRATEGIES AND ALSO IN ASCERTAINING THE ROLE OF REGULAR SCREENING OF SDB IN CHRONIC HEART FAILURE PATIENTS. PATIENTS WILL BE SCREENED USING SLEEP APNEA QUESTIONNAIRES. THEY WILL UNDERGO BASIC LAB EVALUATION AND CARDIAC EVALUATION FOLLOWING WHICH THEY WILL BE SUBJECTED TO OVERNIGHT POLYSOMNOGRAPHY .THE STUDY WILL BE ANALYZED AND THE APNEA HYPOPNEA INDEX (AHI) AND RESPIRATORY DISTURBANCE INDEX (RDI) WILL BE DETERMINED AND PATIENTS WILL BE CLASSIFIED EITHER AS CENTRAL SLEEP APNEA (CSA) OR OBSTRUCTIVE SLEEP APNEA (OSA) . THE PREVALENCE OF SDB WILL BE DETERMINED IN THE STUDY POPULATION AND THE ABOVE INDICES (AHI, RDI )WILL BE COMPARED WITH HEART FAILURE SEVERITY CLASS. |